A hernia is one of the most common ailments of mankind. Basically, a hernia is a weakness or hole in the abdominal wall through which abdominal contents such as bowels may protrude. In general, it relates to the abnormal protrusion of an organ or part of an organ or a portion of tissue through an aperture in its containing cavity. The usual, but not the only, hernia that is typically treated is congenital in origin, called an indirect inguinal hernia, and is due to the failure of the inner lining of the abdomen, called the peritoneum, to seal itself at the opening of the inguinal canal. Inguinal or groin hernias normally occur at one or more of three locations. The first location is in the weakened wall of the inguinal floor of the abdomen in Hesselback's triangle. This type of hernia is called a direct hernia. The second type of hernia is an indirect hernia that occurs at the internal ring adjacent to the vas deferens as it exits the abdomen to become part of the spermatic cord. The third type is a femoral hernia that occurs adjacent and medial to the femoral blood vessels. All hernias represent a potentially life threatening condition and once diagnosed they should be repaired unless there is some contraindication.
There are several different traditional surgical techniques for closing a hernial defect. The surgical repair of an inguinal hernia is a common procedure which surgeons often perform on an outpatient basis. This procedure entails making a formal 3 to 6 inch incision directly adjacent to the hernial defect. The various layers of tissue are cut and pealed back as the hernia area is dissected. This cutting through so many layers of tissue may be extremely traumatic. Moreover, such large incisions require careful post operative care to prevent infection from the outside. Other disadvantages of the conventional hernia surgery are the extended recuperation time and a large unsightly scar. Many other complications are possible: those related to any incision, such as bleeding and infection, and those related to conventional hernia procedures, such as damages to bowel and bladder, nerves and large blood vessels.
A less invasive surgical procedure to repair hernias has been used in conjunction with a laparoscope. Typically a prosthetic patch is inserted down the length of a trocar and forced out of the tube and moved into a desired position. Post-operative problems are decreased by this procedure because of the smaller external wound left by the surgical tube. The patch, however, still can shift before tissue has grown onto it. The patch also can be sutured to the transversalis fiasco or peritoneum to minimize movement. It has typically been difficult to attach patches with sutures using the laparoscope because of difficulties in viewing and in maneuvering through the laparoscope. Thus, while the laparoscopic techniques for hernia repair have generally proven to be less invasive, they still leave something to be desired from the standpoint of effectiveness.
In addition to hernias that are congenital in origin, such as an indirect inguinal hernia, it has been found that external trauma as well as surgical intervention can lead to the formation of hernias. In this regard, it has been found that laparoscopic surgery, itself, can lead to a number of both local and general complications, such as herniation at the site of the percutaneous laparoscopic puncture with or without the formation adhesions thereat. In fact, it is estimated that herniation occurs in an appreciable percentage of these procedures within several months of the procedure. The herniation occurs because the muscle tissue at the location of the puncture is damaged during the procedure. This muscle tissue then weakens and due to internal pressure the intestines or other organs of the abdominal cavity are pushed through this weakened area. Such muscle failure results in a direct hernia, the repair of which typically requires a synthetic mesh to reinforce the damaged muscle tissue.
In U.S. Pat. No. 5,254,133 (Seid) there is disclosed a surgical implantation device arranged to be placed within a patient's body to seal an existing hernial rupture. The device is arranged to be used with a laparoscope to minimize the external wound necessary. The implantation device is arranged to be compressed into an implanting condition for placement at the opening in the transversalis fascia from the interior of the peritoneum using a laparoscope and then to be expanded into a deployed condition to securely seal the opening. The peritoneum can either be left intact and pushed through the fascia opening by the surgical tube and held in place by the surgical implant device at the peritoneum, or can be pierced and the surgical tube and device can be positioned directly in the fascia opening.
While the device of the Seid patent appears to overcome some of the short fallings of traditional surgical hernia repair by introducing the device into the abdominal cavity through a laparoscopic port and then positioned from the inside of the peritoneum outward to treat an existing inguinal hernia, it never the less has its own shortcomings. In this regard one shortcoming of the Seid device is that the laparoscopic procedure utilized to introduce the device for the repair of another hernia, is likely to become a site of a future herniation.
Other prior art relating to the use of reinforcing materials to be implanted at the site of weakened internal tissue to prevent herniation, are found in U.S. Letters Patent No. 5,092,884 (Devereux et al.); 5, 116,357 (Eberbach); 5,141,515 (Eberbach); 5,220,928 (Oddsen et al.); 5,290,217 (Campos); and 5,274,074 (Tang et al.) but none of these are deemed to be suitable for effecting the prevention of post-laparoscopic herniation in a percutaneous puncture.
Thus, a need presently exists for a device and technique to assist in the prevention of post-laparoscopic puncture herniation and eliminate the need for future surgical intervention.
In U.S. Letters Patent No. 5,021,059, which has been assigned to the same assignee as this invention, and whose disclosure is incorporated by reference herein, there is disclosed a closure device and method of use for sealing a small incision or puncture in tissue separating one portion of the body of a living being from another portion thereof, e.g., a percutaneous puncture in an artery, to prevent the flow of a body fluid, e.g., blood, through the puncture. The closure device is arranged to be used with (deployed by) an instrument which comprises a carrier in the form of a tubular member. The tubular member has a proximally located portion and a distally located portion. The latter includes an open free end arranged to be introduced through the incision or puncture. The proximately located portion of the tubular member is arranged to be located out of the body of the being when the distally located portion is extended through the incision or puncture. The closure device comprises three components, namely, an anchor member, a sealing member, and a filament, e.g., suture. The anchor member includes a tissue engaging portion configured to pass through the puncture in one direction but resistant to passage therethrough in the opposite direction. The sealing member is formed of a hemostatic material, such as compressed collagen foam, and has a tissue engaging portion. The filament is connected between the anchor member and the sealing member in a pulley-like arrangement so that they may be moved relative to each other by the application of a pulling force on the filament. The instrument is arranged to expel the anchor member through the puncture, e.g., into the artery, and to draw its tissue engaging portion into engagement with the tissue contiguous with the puncture. The filament extends through the instrument to a point outside the body of the being and is arranged to be drawn in the proximal direction, whereupon the portion of the filament connecting the anchor member causes the tissue engaging portion of the sealing member to move with respect to the anchor member, thereby drawing the anchor member and sealing member together. This action causes the tissue engagement portion of the sealing member to seal the puncture from the flow of fluid therethrough.
In copending U.S. patent application Ser. No. 07/846,322, filed on Mar. 5, 1992, entitled Hemostatic Puncture Closure System and Method of Use, also assigned to the same assignee as this invention, and whose disclosure is incorporated by reference herein, there is disclosed and claimed an improved system for sealing a percutaneous puncture in a blood vessel of a living being, with the puncture comprising an opening in the wall of the blood vessel and a tract contiguous with that opening and extending through tissue overlying the blood vessel. That system basically comprises carrier means, introducer means, and closure means. The closure means comprises anchoring means, sealing means, and filament means, with the filament means coupling the anchoring means and the sealing means. The introducer means comprises a tubular member having a distal free end insertable into the puncture tract and through the opening in the blood vessel wall. The carrier means is insertable through the introducer means and includes means to expel the anchoring means therefrom. Moreover, the carrier means is retractable with respect to the introducer means after the anchoring means has been expelled from the carrier means, so that when it is retracted it draws the anchoring means into engagement with the distal free end of the introducer means. The introducer means and the carrier means are coupled for movement together to draw the anchoring means which is now in engagement with the distal end of the introducer means into engagement with the interior tissue of the vessel generally adjacent the opening in the wall thereof. The filament means is operative to move the anchoring means and the sealing means relative to each other to cause the sealing means to engage tissue generally adjacent the puncture outside of the vessel.
In yet another copending application, Ser. No. 08/012,816, filed on Feb. 3, 1993, entitled Hemostatic Vessel Puncture Closure System Utilizing A Plug Located Within The Puncture Tract Spaced From The Vessel And Method Of Use, which is assigned to the same assignee as this invention, and whose disclosure is incorporated by reference herein, there is disclosed a further improved puncture closure system. That system basically comprises carrier means, introducer means, and closure means. The puncture comprises a tract extending through tissue overlying the blood vessel. In the preferred embodiment, the closure device comprises four components, namely, an anchor member, a sealing member, a spacer member, and a filament, e.g., suture. The anchor member includes a tissue engaging portion configured to pass through the puncture in one direction but resistant to passage therethrough in the opposite direction. The sealing member is formed of a hemostatic material, such as compressed collagen foam. The spacer member is mounted upon the suture, and is slidable thereon, and is positioned between the anchor member and the sealing member. The filament member is connected between the anchor member and the sealing member in a pulley-like arrangement so that the members may be moved relative to each other by the application of a pulling force on the filament. The instrument is arranged to expel the anchor member through the puncture, e.g., into the artery, and to draw its tissue engaging portion into engagement with the tissue contiguous with the puncture. The filament extends through the instrument to a point outside the body of the being and is arranged to be drawn in the proximal direction, whereupon the portion of the filament connecting the anchor member and the sealing member causes the sealing member to move with respect to said anchor member and into engagement with the spacer member thereby drawing the anchor member, spacer member and sealing member together. This action causes the sealing member to seal the puncture from the flow of fluid therethrough. The presence of the spacer member prohibits the sealing member from contacting the arterial wall and thereby possibly entering into the artery where a portion could conceivably break off and flow distally or cause the creation of an embolism.
In still another copending application, Ser. No. 08/064,192, filed on May 17, 1993, entitled Fail Predictable Reinforced Anchor For Hemostatic Closure, which is assigned to the same assignee as this invention, and whose disclosure is incorporated by reference herein, there is disclosed a further improved puncture closure system. In the preferred embodiment of the system specifically disclosed in that application the closure comprises an elongated rigid anchor member formed of a resorbable material, a sealing member formed of a resorbable material, e.g., compressed collagen plug, and a thin resorbable material filament, e.g., a suture, connecting the anchor member and the sealing member. The anchor member is located in the interior of the vessel, with the sealing member being located in the puncture tract. An elongated reinforcing filament or ribbon (either apertured or unapertured), formed of a resorbable material, is incorporated in the elongated anchor member to prevent any portion of it from breaking away in the event that the anchor is loaded beyond its breaking point.
It has been determined that the devices disclosed in the aforementioned applications, with some modifications, as well as other devices, some preferred embodiments of which are set forth hereinafter, can be used to effect the sealing of a percutaneous puncture formed during a laparoscopic procedure of the abdomen or an endoscopic procedure of the thoracic cavity, or some other minimally invasive procedure performed percutaneously. In the case of the sealing of a puncture in the peritoneum, the devices of this invention not only seal the puncture, but also block the egress of tissue therethrough. Thus, the likelihood of herniation is reduced. Moreover, the devices may include means to reinforce the tissue at the tissue opening so that the long-term strength of the scar tissue forming thereat is enhanced. This action may render the puncture site resistant to herniation in the long term.